clinical trials on the effect of immunity 1 (fuzheng 1) on immune reconstitution of hiv patients

Conditions: Acquired Immune Deficiency Syndrome Virus; HIV Infections

Summary: the average period of asymptomatic hiv-infection is 8 years, at this stage, cd4+ t lymphocyte count was reduced gradually at the rate of 50\~100cells/ul/year. when the cd4 t lymphocyte count dropped below 350cells/ul and viral load increased to 105 in aids patients, haart will be carried out. but, cd4 t lymphocyte was 350\~550 cells/ul, there is no intervention measures.

* the average period of asymptomatic hiv-infection is 8 years, at this stage, cd4+ t lymphocyte count was reduced gradually at the rate of 50\~100cells/ul/year. when the cd4 t lymphocyte count dropped below 350cells/ul and viral load increased to 105 in aids patients, haart will be carried out. but, cd4 t lymphocyte was 350\~550 cells/ul, there is no intervention measures. * immunity 1 (fuzheng 1) is composed of herbs which have tonic and detoxific function. the long-term clinical application has proved the safety and effect. it can improve the symptoms and signs in aids patients with the effective rate of 70% and can significantly improve the quality of life. it can also improve and stabilize immune function and inhibit viral replication. the basis study have shown that immunity 1 (fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of il-2, ifn-γ, participate in immune regulation effect, enhance nk cell activity, promote cd3+cd4+t cell proliferation and increase macrophage phagocytes capacity. * through the clinical trials, we are going to evaluate the efficacy and safety of immunity 1 (fuzheng 1) on immune reconstitution of hiv patients in whoⅰ、ii period.

Eligibility criteria:
inclusion criteria: * hiv antibody-positive, confirmed by western blot test * cd 4 counts\> 350 cells / ul and \<550 cells / ul * age ≥ 18 years old and ≤ 70 years old * voluntary participated in this study, signed informed consent form, and could be followed-up exclusion criteria: * patients in who clinical stage ⅲ, ⅳ * participated in clinical trials of other drugs within one month before the experiment * received antiretroviral therapy or are anti-hiv drugs such as nucleoside reverse transcriptase inhibitors (nrtis), non-nucleoside reverse transcriptase inhibitors (nnrtis), protease inhibitors (pis) and fusion-inhibiting agent (fis), integrase inhibitors, inhibitors penetration within one month before the experiment * received immunomodulatory treatment within one month before the experiment liver and kidney dysfunction (ast, alt, t-bil ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value) * patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases * persons suffering from autoimmune diseases * cancer patients which need chemotherapy * pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period * hypersensitive people * patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well

Keywords: aids complementary therapies